FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
K Number: K100646
·
Decision Dec 16, 2010
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
95
Applicant Total
209
Review Days
286
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Basic Information
- Device Name
- AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
- K Number
- K100646
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4260
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- March 5, 2010
- Decision Date
- December 16, 2010
- Product Code
- DTM
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
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AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
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AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
FDA 510(k)
FDA Class 2
·Cardiovascular
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